West Cancer Center

COLORECTAL: METASTATIC: MSI-h: MK-1308A-008

A Phase 2, Multicenter, Multi Arm, Study to Evaluate MK-1308A (Co-formulated Quavonlimab (MK-1308)/Pembrolizumab) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer: (MK-1308A-008)

Title

Merck MK-1308A-008 (Colorectal MSI-h)

Study Title

Site Link

NCT04895722

Malignancy

Colon cancer, rectal cancer, colorectal cancer

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st or later

Investigational Agent

pembrolizumab/quavonlimab, pembrolizumab/favezelimab, pembrolizumab/vibostolimab, pembrolizumab+MK-4830

Drug Class

Various immunotherapy combinations

Brad Somer, MD

Sponsor

Merck Sharp and Dohme

Phase

Phase 2

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

HIstologically confirmed diagnosis of Stage IV CRC
Locally confirmed dMMR/MSI-H
Life expectancy of at least 3 months
Measurable disease
Cohort A:
- Previously treated with 5-FU, oxaliplatin, irinotecan (and anti-EGFR if KRASwt and left-sided tumor)
Cohort B:
- No prior thearpy for stage IV disease
No prior T-cell directed therapy
No concurrent use of high dose steroids
No known CNS mets
No active autoimmune disease
No known HIV or active HBV/HCV
No clinically significant cardiac disease

Objective

Primary
- ORR
Secondary
- DOR
- PFS
- OS

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Adenocarcinoma, MSI-h, dMMR

Dosing Frequency

Control Agents

Study Protocol

Randomized